Recall Z-1979-2014— Nihon Kohden America Inc
Class II · Terminated
Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2014-06-03, terminated 2015-04-28. It names one FDA 510(k) clearance: K102376. Product: CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.. Reason: Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate..
- Recalling firm
- Nihon Kohden America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-03
- Terminated
- 2015-04-28
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Reason for recall
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.